Clinical Trial: Efficacy and Safety Study of KIACTA in Preventing Renal Function Decline in AA Amyloidosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: International Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of the Efficacy and Safety of KIACTA in Preventing Renal Function Decline in Patients With AA Amyloidosi

Brief Summary: The primary purpose of this study is to assess the efficacy and safety of treatment with Kiacta in adult patients with AA Amyloidosis.

Detailed Summary:
Sponsor: C.T. Development America, Inc.

Current Primary Outcome: Time from baseline to a persistent decrease in Creatinine clearance (CrCL) of 40% or more, a persistent increase in Serum Creatinine(SCr) of 80% or more, or progression to end-stage renal disease(ESRD) [ Time Frame: Up to 24 months ]

Original Primary Outcome: all-cause mortality [ Time Frame: Average of 24 months ]

Current Secondary Outcome:

  • rate of change (slope) in creatinine clearance (CrCL) over time [ Time Frame: baseline to primary endpoint, measured every 3 months to end of study visit ]
  • Progression to end-stage renal disease (ESRD) [ Time Frame: baseline, every 3 months to end of study visit ]
  • estimated glomerular filtration rate (eGFR) [ Time Frame: screening, baseline, every 3 months, 12 months , early termination, treatment completion, end of study visit ]
  • serum cystatin C over time [ Time Frame: baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit ]
  • urinary protein/creatinine ratio [ Time Frame: screening, baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit ]
  • serum amyloid A [ Time Frame: baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit ]
  • Time from baseline to persistent decrease in CrCL of 40% or more, a persistent increase in SCr of 80% or more, progression to ESRD, or all-cause mortality [ Time Frame: Up to 24 months ]


Original Secondary Outcome:

  • persistent decrease in creatinine clearance (CrCl) of 40% or more [ Time Frame: baseline to primary endpoint, measured every 3 months to end of study visit ]
  • peristent increase in Serum Creatinine (SCr) of 80% or more [ Time Frame: baseline to primary endpoint, measured every 3 months to end of study visit ]
  • Progression to end-stage renal disease (ESRD) [ Time Frame: baseline, every 3 months to end of study visit ]
  • estimated glomerular filtration rate (eGFR) [ Time Frame: screening, baseline, every 3 months, 12 months , early termination, treatment completion, end of study visit ]
  • serum cystatin C over time [ Time Frame: baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit ]
  • urinary protein/creatinine ratio [ Time Frame: screening, baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit ]
  • serum amyloid A [ Time Frame: baseline, every 3 months, 12 months, early termination, treatment completion, end of study visit ]


Information By: C.T. Development America, Inc.

Dates:
Date Received: October 1, 2010
Date Started: November 2010
Date Completion:
Last Updated: March 9, 2016
Last Verified: March 2016